Consumable data management

ABSTRACT

In examples, a method of controlling customer access to an assay system comprises (a) receiving a system identifier; (b) identifying said system identifier; and (c) utilizing information obtained from the system identifier to perform one or more operations selected from: (i) enabling full access to said system and/or a consumable used in said system; (ii) enabling partial access to said system and/or a consumable used in said system; or (iii) denying access to said system and/or a consumable used in said system.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of copending U.S. patent applicationSer. No. 17/185,293, filed Feb. 25, 2021, which is a continuation ofU.S. patent application Ser. No. 16/052,711, filed Aug. 2, 2018, nowU.S. Pat. No. 10,963,523, which is a continuation of U.S. patentapplication Ser. No. 15/583,370, filed May 1, 2017, now U.S. Pat. No.10,068,020, which is a continuation of U.S. patent application Ser. No.14/283,689, filed May 21, 2014, now U.S. Pat. No. 9,659,096, which is adivisional of U.S. patent application Ser. No. 13/191,000, filed Jul.26, 2011, now U.S. Pat. No. 8,770,471, which claims the benefit of U.S.Provisional Application Ser. Nos. 61/462,024, filed January 27, 2011 and61/400,441, filed Jul. 27, 2010. The entire contents of each of theseapplications are incorporated herein by reference.

FIELD OF THE INVENTION

The present teaching relates to methods, devices and systems forassociating consumable data with an assay consumable used in abiological assay.

BACKGROUND OF THE INVENTION

Numerous methods and systems have been developed for conducting assays.These methods and systems are essential in a variety of applicationsincluding medical diagnostics, veterinary testing, food and beveragetesting, environmental monitoring, manufacturing quality control, drugdiscovery, and basic scientific research. During the manufacture and useof reagents and other consumables used in biological assays, thereagents and consumables are typically coded and labeled by themanufacturer in order to track them. In addition, a myriad of analyticalparameters must be tracked in order to understand the analytical resultsof any given assay, often requiring input from various parallel trackingsystems supplied by the manufacturer, customer or both.

SUMMARY OF THE INVENTION

The present invention provides an assay system configured to use anassay consumable in the conduct of an assay, the assay consumablecomprising an assay consumable identifier and the assay systemcomprising: (a) a storage medium including a consumable data repositorycomprising local consumable data; and (b) a reader adapted to readconsumable data from the consumable identifier, wherein the consumabledata and local consumable data comprises (i) consumable identificationand/or configuration information, and (ii) one or more steps of an assayprotocol that can be applied by the system in the conduct of an assayusing the consumable, wherein the system is configured to receiveupdates of the repository, the updates comprising additional consumabledata and at least one consumable data type comprising:

(x) one or more analytical tools that can be applied by the system toanalyze data generated during and/or after the conduct of an assay,

(y) assay system maintenance information,

(z) system-consumable promotional information,

(xx) system and/or consumable technical support information, or

(yy) combinations thereof.

In one embodiment, the assay system of the invention includes aninterface configured to send and/or receive consumable data to and/orfrom a vendor computing system.

The invention also provides a method of using an assay system configuredto use an assay consumable in the conduct of an assay, the assayconsumable comprising an assay consumable identifier and the assaysystem comprising: (a) a storage medium including a consumable datarepository comprising local consumable data; and (b) a reader adapted toread consumable data from the consumable identifier, wherein theconsumable data and local consumable data comprises (i) consumableidentification and/or configuration information, and (ii) one or moresteps of an assay protocol that can be applied by the system in theconduct of an assay using the consumable, wherein the system isconfigured to receive updates of the repository, the updates comprisingadditional consumable data and at least one consumable data typecomprising (x) one or more analytical tools that can be applied by thesystem to analyze data generated during and/or after the conduct of anassay, (y) assay system maintenance information, (z) system-consumablepromotional information, (xx) system and/or consumable technical supportinformation, or (yy) combinations thereof, the method comprising thesteps of:

-   -   (a) reading consumable data from the consumable identifier;    -   (b) adjusting one or more operations performed by the system        before, during, and/or after the conduct of the assay by the        system based on the consumable data;    -   (c) conducting an assay in the assay system using the assay        consumable; and    -   (d) receiving the updates of the repository.

Moreover, also contemplated is a method of enabling use of an assaysystem by a system/consumable vendor, the assay system being configuredto use an assay consumable in the conduct of an assay comprising anassay consumable identifier and the assay system comprising (a) astorage medium comprising local consumable data; and (b) a readeradapted to read consumable data from the consumable identifier, whereinthe system/consumable vendor maintains a master consumable datarepository comprising consumable data; the method comprising the step ofproviding consumable data to a customer from the master consumable datarepository to enable use in the system of the consumable data.

Still further, the invention includes an assay system configured to usean assay consumable in the conduct of an assay, the assay consumablecomprising an assay consumable identifier and the assay systemcomprising: (a) an interface configured to send and/or receiveconsumable data to and/or from a vendor computing system, (b) a storagemedium comprising local consumable data, and (c) a reader adapted toread consumable data from the consumable identifier, wherein theconsumable data comprises:

(i) consumable identification and/or configuration information, and

(ii) one or more steps of an assay protocol that can be applied by thesystem in the conduct of an assay using the consumable.

Another embodiment of the invention is a method of tracking use of assayconsumables in an assay system, the assay consumable comprising an assayconsumable identifier and the assay system comprising (a) an interfaceconfigured to send and/or receive consumable data to and/or from avendor computing system, (b) a storage medium comprising localconsumable data, and (c) a reader adapted to read information from theconsumable identifier, wherein the consumable data and local consumabledata comprises (i) consumable identification and/or configurationinformation, and (ii) one or more steps of an assay protocol that can beapplied by the system in the conduct of an assay using the consumable,the method comprising the steps of:

(a) reading consumable data from the consumable identifier;

(b) configuring the assay system for use of the assay consumable in theconduct of an assay in the system using the consumable data;

(c) conducting an assay in the assay system using the assay consumable;

(d) storing system-consumable use information to the storage medium; and

(e) sending system-consumable use information to the vendor computingsystem via the interface.

Also included is a method of controlling customer access to an assaysystem by a system vendor wherein the system comprises a systemidentifier, the method comprising the steps of:

(a) receiving the system identifier from a customer, wherein the systemidentifier is sent to a vendor computing system;

(b) identifying the system identifier by the vendor; and

(c) performing one or more operations selected from:

-   -   (i) enabling full access to the apparatus and/or a consumable        used in the apparatus;    -   (ii) enabling partial access to the apparatus and/or a        consumable used in the apparatus; or    -   (iii) denying access to the apparatus and/or a consumable used        in the apparatus.

A further embodiment of the invention is a method of generating andmaintaining consumable data and consumable data for a consumablecomprising:

(a) manufacturing a consumable used in the conduct of an assay;

(b) generating a database comprising consumable data associated with theconsumable, wherein the database comprises information used to associatethe consumable data for the consumable; and

(c) maintaining the database on a server.

Moreover, the invention includes a method of providing consumable datafor a consumable to a customer comprising:

(a) receiving a query from the customer for consumable data associatedwith the consumable; and

(b) sending consumable data for the consumable by a medium comprisingemail attachment, a compact disc, a memory card/stick, a flash drive, aweb data storage service, or combinations thereof.

Still further, the invention provides a method of providing consumabledata for a consumable to a customer comprising:

(a) receiving a query from a customer system via a direct interface forconsumable data associated with the consumable, wherein the directinterface comprises an internet connection between the customer systemand a vendor server; and

(b) sending consumable data for the consumable via the interface to thecustomer system.

Also contemplated is a computer readable medium having stored thereon acomputer program which, when executed by a computer system operativelyconnected to an assay system, causes the assay system to perform amethod of conducting an assay on the assay system, wherein the assaysystem is configured to use an assay consumable in the conduct of theassay and the assay system comprises: (a) a storage medium including aconsumable data repository comprising local consumable data; and (b) areader adapted to read consumable data from the consumable identifier;the method comprising the steps of:

(a) reading consumable data from a consumable identifier associated withthe assay consumable, wherein the consumable data and local consumabledata comprises: (i) consumable identification and/or configurationinformation, and (ii) one or more steps of an assay protocol that can beapplied by the system in the conduct of the assay using the consumable;

(b) adjusting one or more operations performed by the system before,during and/or after the conduct of the assay based on the consumabledata;

(c) conducting the assay in the assay system using the assay consumable;and

(d) receiving updates of the repository, the updates comprisingadditional consumable data and at least one consumable data typecomprising (x) one or more analytical tools that can be applied by thesystem to analyze data generated during and/or after the conduct of anassay, (y) assay system maintenance information, (z) system-consumablepromotional information, (xx) system and/or consumable technical supportinformation, or (yy) combinations thereof.

In an additional embodiment, the invention provides a computer readablemedium having stored thereon a computer program which, when executed bya computer system, causes the computer system to perform a method ofenabling use of an assay system by a system/consumable vendor, the assaysystem being operatively connected to the computer system and configuredto use an assay consumable in the conduct of an assay comprising anassay consumable identifier and the assay system comprising (a) astorage medium comprising local consumable data; and (b) a readeradapted to read consumable data from the consumable identifier, whereinthe system/consumable vendor maintains a master consumable datarepository comprising consumable data; the method comprising the step ofreceiving consumable data from the master consumable data repository toenable use of the consumable in the system.

In a specific embodiment, a computer readable medium is provided havingstored thereon a computer program which, when executed by a computersystem, causes the computer system to perform a method of tracking useof assay consumables in an assay system operatively connected to thecomputer system, the assay consumable comprising an assay consumableidentifier and the assay system comprising: (a) an interface configuredto send and/or receive consumable data to and/or from a vendor computingsystem, (b) a storage medium comprising local consumable data, and (c) areader adapted to read information from the consumable identifier, themethod comprising the steps of:

(a) reading consumable data from the consumable identifier, wherein theconsumable data and local consumable data comprises (i) consumableidentification and/or configuration information, and (ii) one or moresteps of an assay protocol that can be applied by the system in theconduct of an assay using the consumable;

(b) configuring the assay system for use of the assay consumable in theconduct of an assay in the system using the consumable data;

(c) conducting an assay in the assay system using the assay consumable;

(d) storing system-consumable use information to the storage medium; and

(e) sending system-consumable use information to the vendor computingsystem via the interface.

Additionally, the invention includes a computer readable medium havingstored thereon a computer program which, when executed by a computersystem, causes the computer system to perform a method of controllingcustomer access to an assay system by a system vendor wherein the systemcomprises a system identifier, the method comprising the steps of:

(a) receiving the system identifier from a customer, wherein the systemidentifier is sent to a vendor computing system;

(b) identifying the system identifier by the vendor; and

(c) performing one or more operations selected from:

-   -   (i) enabling full access to the apparatus and/or a consumable        used in the apparatus;    -   (ii) enabling partial access to the apparatus and/or a        consumable used in the apparatus; or    -   (iii) denying access to the apparatus and/or a consumable used        in the apparatus.

Still further, the invention includes a computer readable medium havingstored thereon a computer program which, when executed by a computersystem, causes the computer system to perform a method of generating andmaintaining consumable data and consumable data for a consumablecomprising:

(a) generating a database comprising consumable data associated with theconsumable, wherein the database comprises information used to associatethe consumable data with the consumable; and

(b) maintaining the database on a server.

Also contemplated is a computer readable medium having stored thereon acomputer program which, when executed by a computer system, causes thecomputer system to perform a method of providing consumable data for aconsumable to a customer, the method comprising:

(a) receiving a query from the customer for consumable data associatedwith the consumable; and

(b) sending consumable data for the consumable by a medium comprisingemail attachment, a compact disc, a memory card/stick, a flash drive, aweb data storage service, or combinations thereof.

Moreover, the invention includes a computer readable medium havingstored thereon a computer program which, when executed by a computersystem, causes the computer system to perform a method of providingconsumable data for a consumable to a customer, the method comprising:

(a) receiving a query from a customer system via a direct interface forconsumable data associated with the consumable, wherein the directinterface comprises an internet connection between the customer systemand a vendor server; and

(b) sending consumable data for the consumable via the interface to thecustomer system.

In a preferred embodiment, the assay consumable comprises at least oneassay test site for the assay, and preferably, the test site comprises aplurality of distinct assay domains, at least two of the domainscomprising reagents for measuring different analytes. The test sites canbe wells and/or chambers in the assay consumable. In one specificembodiment, the assay consumable comprises a plurality of wells and theconsumable further includes at least one element comprising a plate top,plate bottom, working electrodes, counter electrodes, referenceelectrodes, dielectric materials, electrical connections, dried and/orliquid assay reagents, or combinations thereof. Alternatively oradditionally, the assay consumable comprises a flow cell and theconsumable can be a cartridge further comprising at least one elementincluding one or more fluidic components, one or more detectioncomponents, one or more assay cells, reagents for carrying out an assay,working electrodes, counter electrodes, reference electrodes, dielectricmaterials, electrical connections, dried and/or liquid assay reagents,or combinations thereof In this embodiment, the cartridge comprises atleast one assay cell that includes a plurality of distinct assaydomains, at least two of the domains comprising reagents for measuringdifferent analytes. Still further, the assay consumable can be acontainer adapted to receive one or more assay reagents.

The invention provides systems, methods, and computer readable mediaconfigured to send, receive, and make use of consumable data associatedwith a consumable in an assay system. In one embodiment, the consumabledata comprises information used to identify at least one elementincluding (i) the assay consumable, (ii) one or more test sites withinthe consumable, (iii) a reagent and/or sample that has been or will beused in the consumable, or (iv) combinations thereof. Still further, theconsumable data is used to distinguish a first test site within theconsumable from a different test site within the consumable.

Additionally, consumable data can be consumable information comprisinglot identification information, lot specific analysis parameters,manufacturing process information, raw materials information, expirationdate, calibration data, threshold information, the location ofindividual assay reagents and/or samples within one or more test sitesof the assay consumable, Material Safety Data Sheet (MSDS) information,or combinations thereof.

Still further, consumable data includes sample information comprisingthe location of samples within the at least one test sites of the assayconsumable, assay results obtained on the assay consumable for thesample, identity of samples that have been and/or will be assayed in theassay consumable, or combinations thereof. In addition, consumable dataalso includes chain of custody information, including but not limited toinformation regarding the control, transfer, analysis of the sample, orcombinations thereof. Moreover, chain of custody information alsoincludes customer identification, time and date stamp for the assay,location of the assay system during the assay, calibration and QC statusof the assay system during the assay, custody and/or locationinformation for the assay consumable before and after the conduct of theassay, assay results for the sample; time, date, manufacturing personnelor processing parameters for one or more steps during the manufacture ofthe assay consumable; custody, location and or storage conditions forthe assay consumable following manufacture and/or between steps duringthe manufacture of the assay consumable; or combinations thereof

Still further, consumable data includes consumable/test site informationcomprising consumable type and structure, location and identity of assayreagents included with the assay consumable, location and identity ofassay reagents within an assay test site of the assay consumable, orcombinations thereof.

Also contemplated is consumable data that includes assay processinformation comprising assay parameters to be applied by the readerduring the assay, a sequence of steps to be applied by the reader duringthe assay, the identity, concentration, and/or quantity of assayreagents to be used or added during the assay, the type or wavelength oflight to be applied and/or measured by the reader during the assay, thetemperature to be applied by the reader during the assay, an incubationtime for the assay, statistical or analytical methods to be applied bythe reader to raw data collected during the assay, or combinationsthereof. In a specific embodiment, the assay conducted in the system isa multi-step assay and the assay process information relates to a stepor step(s) of the multi-step assay. Therefore, consumable/test siteinformation comprises information concerning assays previously performedby a reader on one or more test sites of the consumable; informationconcerning assays to be performed by an assay reader or a componentthereof on one or more test sites within the consumable; or combinationsthereof.

Moreover, consumable data also includes consumable security informationcomprising information concerning assay consumable authentication;information concerning appropriate placement and/or orientation of theassay consumable in the system; information concerning defects in theassay consumable and/or a test site thereof or combinations thereof.

The consumable data can be used by the system to adjust the operation ofat least one component of the assay system comprising one or moresensors; mechanisms to transport the assay consumables into and out ofthe system; mechanisms to align and orient the assay consumables withthe one or more sensors and/or with electrical, mechanical or fluidicinterfaces in the system; mechanisms, electronics or software to trackand/or identify assay consumables; mechanisms to store, stack, moveand/or distribute one or more consumables; or combinations thereof.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates the generation and storage of consumable data andconsumable data by a consumable manufacturer.

FIG. 2 illustrates the distribution of consumable data to a customer inresponse to a query for consumable data.

FIG. 3 the use of consumable data to verify authorized use of aconsumable in an assay system.

FIG. 4 illustrates the master repository on the CD server, its contentsand/or interface with additional vendor directories.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

Unless otherwise defined herein, scientific and technical terms used inconnection with the present invention shall have the meanings that arecommonly understood by those of ordinary skill in the art. Further,unless otherwise required by context, singular terms shall includepluralities and plural terms shall include the singular. The articles“a” and “an” are used herein to refer to one or to more than one (i.e.,to at least one) of the grammatical object of the article. By way ofexample, “an element” means one element or more than one element.

The assay consumables and systems used in the present invention includea variety of devices and configurations. In one embodiment, the assaysystem used in the present invention includes an assay reader capable ofconducting a biological assay using an assay consumable. The assayconsumable comprises an identifier (referred to alternatively throughoutthe specification as an identifier, a consumable identifier, or an assayconsumable identifier) and the assay system, reader or a componentthereof comprises an identifier controller that interacts with theidentifier. As described hereinbelow, the identifier includesinformation concerning the assay consumable, which cancan include but isnot limited to, how the consumable is manufactured and handled prior touse and how the consumable is used in an assay system (referred tocollectively as “consumable data”). Therefore, the assay system isconfigured to use an assay consumable in the conduct of an assay, andthe assay system includes a reader adapted to (i) read information froman assay consumable identifier associated with the assay consumable; andoptionally, (ii) erase information from the assay consumable identifier;and/or (iii) write information to the assay consumable identifier.

In a specific embodiment, the invention provides an assay systemconfigured to use an assay consumable in the conduct of an assay,wherein the assay consumable includes an assay consumable identifier asdescribed herein and the assay system includes (a) a storage mediumcomprising consumable data repository; and (b) a reader adapted to readinformation from the consumable identifier. In one embodiment, thesystem comprises a storage medium including a consumable data repositorycomprising local consumable data. The local consumable data stored tothe assay system includes consumable identification and/or configurationinformation and one or more steps of an assay protocol that cancan beapplied by the system in the conduct of an assay using a consumable. Forexample, the assay consumable identifier includes information that canbe used to identify a specific consumable, e.g., lot specificinformation for a given lot of consumables and/or information that isspecific to an individual consumable, and the corresponding localconsumable data stored to the assay system includes information that isused to identify a consumable associated with the system, e.g., as amember of a given lot or as an individual consumable within a lot and italso includes information that is used by the system once the consumableis identified to carry out an assay protocol using that consumable.Still further, the consumable data (and/or local consumable data) caninclude one or more analytical tools that can be applied by the systemto analyze data generated using that consumable, system and/orconsumable technical support information or combinations thereof.Moreover, the system can also be configured to receive updates to theconsumable data repository from a remote storage medium, wherein thoseupdates include additional consumable data, including but not limited toadditional consumable identification and/or configuration information,assay protocol information, and one or more of the following: (x) one ormore analytical tools that can be applied by the system to analyze datagenerated during and/or after the conduct of an assay, (y) assay systemmaintenance information, (z) system-consumable promotional information,and (xx) system and/or consumable technical support information.

The use of the identifier/consumable data in the system is illustratedin FIGS. 1-4 . FIG. 1 shows how consumable data is generated, stored andused by the manufacturer, distributor, or supplier (referred to hereinas “vendor”). First, the vendor generates a consumable and/or a set orlot of consumables (101) and for that consumable or lot of consumables,consumable data is generated using a consumable data (CD) creationsystem (102) and stored to a consumable identifier (103) associated withthe consumable or lot of consumables (step i). The consumable data isgenerated by the consumable vendor before, during and/or after theindividual consumable and/or lot of consumables are made and/ordistributed. The CD creation system generates a database of CDinformation for that consumable or lot, i.e., a CD database, to whichconsumable data is stored. The CD database is sent to a CD Server (104)which includes a master repository of all consumable data. In addition,the CD creation system stores information that is used to associate agiven consumable identifier with consumable data in the masterrepository. The CD creation system and/or CD Server are located on aremote computing system, i.e., a computing system remote from the assaysystem and/or the customer or customer, e.g., a site maintained by thevendor. Therefore, as shown in FIG. 1 , the vendor generates consumabledata for a consumable or lot (a) and stores that information to aconsumable identifier (b) associated with that consumable or lot. The CDsystem also (step ii) generates a CD database; (step iii) storesconsumable data to the CD database; and (step iv) sends the CD databaseto the CD Server (c), which includes a master repository of allconsumable data.

FIG. 2 illustrates one method of distributing consumable data to acustomer or designated user of a customer (referred to collectivelyherein as a “customer”). Upon receipt of an order from a customer orwhen the consumable or lot is manufactured (step i), the vendorgenerates, stores and sends a CD database to the CD server (201) (stepii). The CD database can include order fulfillment information, i.e., asummary of the components of the order for a given customer so that thesystem can verify that all components of the order have been supplied tothe customer. The customer receives the consumable (202), includingconsumable identifier (203), and contacts the consumable with the assaysystem (204) in preparation for the conduct of an assay (step iii), thesystem reads the information stored to the assay consumable identifier(203) and that information is used by the system to identify theconsumable (202) (step iv). The system reviews the consumable datastored locally on the system in a local storage medium (referred to inFIG. 2 as “local CD”) to identify that consumable data stored to thestorage medium that can be used for the conduct of an assay using agiven consumable. If the storage medium includes the consumable data forthat consumable or lot, the consumables can be used in the system (stepv). If the storage medium does not include consumable data for thatparticular consumable or lot of consumables, the system can query thecustomer for that consumable data and the customer can communicate withthe vendor to receive the requisite consumable data, e.g., via email,compact diskette, memory card/stick, flash drive, web data storageservice, etc. (step vi). The vendor sends consumable data binary files(including but not limited to encrypted XML files) to the customer,e.g., as an email attachment to a customer email account, the customerloads that file attachment to the assay system and the system softwarestores the consumable data to the local system consumable datarepository. The consumable/lot of consumables can then be used in theinstrument (step vii).

In an alternative embodiment, the CD server can be connected to thesystem via a direct interface which can automatically obtain theconsumable data from the CD server if it is not available on the systemlocally. In this embodiment, the vendor generates, stores and sends a CDdatabase to the CD server for a consumable order and/or lot ofconsumables, as shown in FIG. 2 and as described above. Thereafter thecustomer receives the consumable, order and/or lot and contacts thesystem with the consumable identifier to enable the system to identifythe consumable or lot. The system software queries the system consumabledata repository for the consumable data associated with that consumableidentifier and if that consumable data is available locally on thesystem, the software will adjust the system based on the consumabledata, if necessary. If the consumable data is not present in the systemconsumable data repository, the system will either (i) prompt thecustomer to manually obtain the consumable data from the vendor, or (ii)automatically, via a direct interface with the CD server, obtain theconsumable data from the CD server and store that information locally onthe system consumable data repository. Once the consumable data isavailable locally on the system, the software adjusts the system basedon the consumable data, if necessary, and conducts an assay. Once theconsumable data is available locally on the system, the consumable orlot can be used in the system to conduct an assay and display the assayresults to the customer. In a specific embodiment, the system softwareadjusts the output to the customer based on the consumable data.

In addition, the CD server can periodically send consumable data for newlots of consumables/consumable types to a customer assay system, e.g.,via email, CD, memory card/stick, flash drive and/or via a remoteinterface between the system and the CD server. The storage mediumcomprises a consumable data repository including the consumable data andthe assay system is configured to receive updates to the repository froma remote storage medium, e.g., via email, CD, memory card/stick, flashdrive and/or via a remote interface.

FIG. 3 illustrates the verification of the consumable data by the systemsoftware and the consequences of that procedure. First, the customerinserts the consumable (301), with consumable identifier (302), into thesystem (303) (or otherwise contacts the consumable identifier with thecontroller on the system) and the system software identifies theconsumable via the consumable identifier (302). The system will attemptto associate that identifier with the consumable data stored locally onthe system repository. If the consumable data is verified and valid, thesystem will process the consumable and display the results of thatprocessing step to the customer. But if the consumable data is invalidor unverifiable, although the consumable will be processed by thesystem, the results of that analysis will not be displayed or otherwiseavailable to the customer until the consumable data is verified by thesystem software.

In addition, the invention provides a method of controlling customeraccess to an assay system and/or assay consumable by a vendor whereinthe system comprises a system identifier, and the method includesreceiving the system identifier from a customer, wherein the systemidentifier is sent to a vendor computing system; identifying the systemidentifier by the vendor; and performing an operation comprising:

-   -   (i) enabling full access to the apparatus and/or an assay        consumable used in that apparatus;    -   (ii) enabling partial access to the apparatus and/or an assay        consumable used in that apparatus; and    -   (iii) denying access to the apparatus and/or an assay consumable        used in that apparatus.

The system identifier includes information that uniquely identifies theassay system, e.g., a serial number or other identification code that isgenerated and used by the vendor to identify the assay system. Thesystem identifier is generated by the vendor during or after themanufacturing process and/or as the system is being prepared forshipment or transfer to a customer.

In one embodiment, the step of enabling access, either full or partial,includes the step of sending an access code from the vendor to thecustomer, thereby enabling access to the system. The access code can bea full or a partial access code that enables different functionalitiesin the system. In one embodiment, the access code is a partial accesscode that enables the system to operate in a demonstration mode. Thepartial access code can be time-limited. Alternatively, the access codecan be a full access code that enables the system to be fullyoperational.

As shown in FIG. 4 , the CD server (401) includes a master repository(402) that comprises one or more directories of (i) consumable data;(ii) system data; and (iii) customer data. In addition or alternatively,the data contained in or more of directories (i)-(iii) can be suppliedto the master repository by an interface between the CD server and oneor more supplemental vendor directories. In one embodiment, the masterrepository comprises (i) a master customer data directory (403); (ii) amaster system identifier directory (404); and (iii) a master customerdata directory (405). In a preferred embodiment, customer data issupplied to the CD server via an interface to a supplementalvendor-customer directory that maintains customer data. Customer datacan be stored in one or more supplemental vendor-customer directories,each connected via an interface to the CD server. The master CD databasecomprises a plurality of CD directories, each generated for a consumableor lot of consumables. The master system identifier directory includesthe unique system identifiers for each system manufactured and/ordistributed by the vendor. And the master customer directory and/orsupplemental vendor-customer directories that interface with the CDserver include information related to each customer of the vendor, e.g.,contact information for the customer and individual customers at thatcustomer, billing information, pricing information, shippinginformation, order history, etc.

In a specific embodiment, when a system is manufactured and/or preparedfor shipment, a vendor generates a system identifier for that system.The system identifier is stored in the master system identifierdirectory or available via an interface between a supplemental vendordirectory to the CD server. If the system is ordered by a customer,order information, e.g., purchase order, a related quote, pricing, termsand conditions of sale or lease, related service agreements, etc., andcustomer information is stored to the master customer directory and/orto one or more supplemental vendor-customer directories that interfacewith the CD server. In this regard, the unique system identifier forthat system is associated with the customer that has purchased thatsystem in the master repository, as well as any information regardingrelated purchases by that customer. Shipping information for that systemto the customer is also available in the customer directories(s) andonce the system is shipped the customer receives a shippingconfirmation, a copy of which is also stored in the customerdirectories. The customer receives the system and in a preferredembodiment, once installation and training on the system is completed,if required, the system software connects to the CD server via a remoteinterface between the system and the CD server to enable interactionbetween the two. The system initially connects to the CD server toconfirm that system installation, and training is completed andsuccessful and the CD server records that confirmation. Alternatively,if a remote connection is not enabled on the system, the customerreceives a confirmation code, system login, and/or email address fromthe system once the system is installed and training is completed andthe customer can login to the CD server via that confirmation code,system login and/or email, thereby providing a customer login to the CDserver that provides a separate vendor-customer interface without adirect connection between the system and the CD server. The separatevendor-customer interface can be a portal on a vendor hosted customeraccessible website via a password and/or the customer and the CD servercan communicate via an email exchange server configured to send andreceive emails between customers and the CD server (referred tocollectively as an “indirect interface” between the customer and the CDserver). Therefore, the vendor can communicate with the customer via adirect system-CD interface (referred to as a “direct interface”) and/orvia an indirect interface. As described above, the customer can thenpurchase consumables, the system will read the consumable identifier andconfirm consumable data is stored locally, receive consumable data fromthe CD server, directly or indirectly, if necessary, and then the systemwill be enabled to use that consumable or lot.

Once the customer and vendor have a means of communicating via a director indirect interface, the customer and vendor can interact in a varietyof ways and because the vendor has the ability to trackcustomer-specific use information for the system and consumablespurchase and/or used by the customer, communication between the partiescan be more meaningful and productive. For example, the customer canbrowse and/or purchase vendor products, receive customer assistance,schedule service calls, etc. via the direct or indirect interface.Because the vendor is able to track customer activity and purchases soclosely via the consumable identifier/CD server, the vendor can tailorits interactions with the customer based on that information. Forexample, because the vendor is aware of the customer's order history,the vendor can send the customer promotional materials for productsrelated to those products the customer has purchased/used in the past.Similarly, because the vendor tracks information related to thecustomer's system, the vendor can send the customer preventativemaintenance tips and reminders, general or specific customer trainingand seminars based on the customer's unique needs (and informed bytracking consumable data for that customer), and information regardingsystem service, warranty repairs, service contract information andreminders, etc.

In one embodiment, the vendor tracks use of consumables by an assaycustomer and the consumable data stored to the assay system includessystem-consumable use information. To facilitate consumable usetracking, the assay system is configured to send system-consumable useinformation directly or indirectly to the CD server. If a directinterface is enabled between the system and the CD server,system-consumable use information can be sent automatically. If,however, the direct interface is not enabled, system-consumable useinformation can be provided indirectly by the customer to the CD server.In this embodiment, the system can periodically prompt the customer toprovide system-consumable use information to the vendor via the indirectinterface. The vendor can maintain a directory of customer consumableinformation to track consumable use and information from that directoryis used to send consumable data, via the direct or indirect interface,that can be relevant to a customer based on prior consumable and/orsystem use. If the direct interface is enabled, the assay system can beconfigured to receive assay system maintenance and/or promotionalinformation from a vendor computing system related to an individualcustomer's prior consumable and/or system use.

The vendor can also track and/or convey system maintenance informationto the customer, e.g., monitoring system and/or system components usage,service history, system troubleshooting information, the results ofdiagnostics run on the system, control charting, periodic maintenancescheduling, warranty information regarding the system and/or a componentthereof, or combinations thereof. The system software can be programmedto monitor various components of the system and automatically or whenprompted, send monitoring reports to a remote computing system and/or toa service technician. If a direct interface is not enabled, the systemcan prompt the customer to send monitoring reports to the CD server viaan indirect interface. In addition or alternatively, such systemmonitoring reports can be accessed by a service technician charged withthe task of maintaining and/or servicing the system on site or remotely.In a specific embodiment in which a direct interface is enabled, the CDserver monitors system component usage and/or warranty information andbased on standard system component lifetimes and/or warranty terms,schedules periodic system/component maintenance and/or upgrades by aservice technician. In addition, the CD server can maintain a log of theservice history for a given assay system and schedule a service call bya service technician (this can be done using either a direct or indirectinterface). The remote computing system can also send an individualassay system software upgrades via a direct or indirect interface.

In addition, one or more of the following system components and/oractions can be monitored by the system software including, but notlimited to, expected motor positions during normal usage, positionalerrors for each expected motor position, corrective actions and/orattempted corrective actions taken by the system in the event of a motorpositioning error, and error frequencies; component usage, e.g., theapproximate time the component has been on in the system, and in apreferred embodiment, the system also tracks the relative lifespan ofthat component under normal use conditions; locking mechanisms attempts,re-attempts, and failures; bar code reader attempts, re-attempts, andfailures; approximate temperature of one or more components in thesystem, error warnings, database performance and capacity, instrumenthard disk capacity, software and firmware version and patches, customerlogin/logout, system startup and shutdown, and the like. In aparticularly preferred embodiment involving a system designed to conductelectrochemiluminescence measurements using assay consumables, thesystem software can also be programmed to monitor the time the camerahas been on and approximate temperature, the use cycle of latches withinthe system, bar code reader attempts, re-attempts, and failures,consumable locking and unlocking events, ECL waveform voltage andintegrated current, image processing analysis accuracies and failures,consumable type, kit, owner, bar code, and time stamp for eachconsumable run in the system, or combinations thereof. Still further,the system software can also monitor experiments conducted in thesystem, e.g., when, by whom, and which type of consumable(s) were usedin that experiment. Such system-use monitoring information can be sentvia a direct and/or indirect interface, to the CD server to enable thevendor to schedule appropriate support, service and/or maintenance onthe system.

In another embodiment, by tracking use of an assay system, a vendor canprovide use and/or purchasing assistance. For example, a vendor cantrack consumable use and purchase history and based on the consumabledata for a given lot or consumable, the vendor can monitor theexpiration data of a given lot or consumable and notify the customer ofan approaching expiration date for a lot or consumable. Tracking use ofan assay system/consumable type can also enable a vendor to track arelative schedule/frequency of consumable use and notify the customerthat the customer's consumable supply needs to be replenished. If adirect interface is enabled, the system can also be configured toorder/re-order consumables and the system can be further configured totrack and confirm consumable orders from a vendor. If a direct interfaceis not enabled, the system can monitor consumable use and inventory andprompt the customer to replenish a supply of one or more consumables.(In this regard, a system receives lot size information via theconsumable identifier and by monitoring consumable usage, it can promptthe customer when the available consumable supply in a given lot hasbeen diminished to a minimum level.) Moreover, by tracking consumableuse, the vendor can send the customer information regarding custom assaydesign services for a specific custom consumable type based on thecustomer's order/consumable use history. A direct or indirect interfacecan also provide customer training modules, consulting services, and/orlive customer service assistance capabilities to facilitate the customerexperience (i.e., live-chatting) (referred to collectively as systemand/or consumable technical support information).

In another embodiment, tracking consumable/system use enables the vendorto send promotional material to the customer, e.g., when a new type orlot of consumables historically used by a given end-customer, the vendorcomputing system sends consumable data to the customer regarding thosenew products. Such promotional materials can also relate to new assaysystems that might be of interest to the customer based on thatcustomer's prior usage. The remote computing system can also send acustomer literature references that can relate to one or moreconsumables/systems used by a given customer.

These and other specific examples of consumable data are described inmore detail hereinbelow.

Assay Systems, Consumables & Methods of Use

The assay systems contemplated by the present invention are used toconduct any type of diagnostic or analytical method known in the art.Such analytical methods include but are not limited to clinicalchemistry assays (e.g., measurements of pH, ions, gases andmetabolites), hematological measurements, nucleic acid amplificationassays (e.g., polymerase chain reaction (PCR) and ligase chain reactionassays), immunoassays (e.g., direct, sandwich and/or competitiveimmunoassays and serological assays), oligonucleotide ligation assays,and nucleic acid hybridization assays. Any biological reagent that mightbe used in such analytical methods can be used in such systems,including but not limited to nucleic acids, nucleotides,oligonucleotides, DNA, RNA, PNA, primers, probes, antibodies orfragments thereof, antigens, small molecules, e.g., drugs or prodrugs,streptavidin, avidin, and biotin.

These systems can be portable, e.g., hand-held, and/or operated within afixed laboratory or field setting, alone or in combination with one ormore additional components, assay devices or systems. These systems canbe used in a variety of applications, from field operations tolaboratory settings, in a wide variety of industries, including but notlimited to, medical, clinical, forensic, pharmaceutical, environmental,veterinary, biological, chemical, agricultural, waste management,hazardous chemical, drug testing, and in defense applications, e.g., forthe detection of biological warfare agents. The assay systems andconsumables used in the present invention can detect an analyte ofinterest by any suitable method, including but not limited to, optical,electromechanical, radiowave, electromagnetic, colorimetric,fluorimetric, chemiluminescent, electrochemiluminescent, radiochemical,nuclear magnetic resonance, enzymatic, fluorescent, particle-count, andcell-count based detection.

The assay consumable includes devices in which one or more steps of anassay process are conducted and such devices can include one or moretest sites where an assay measurement is conducted. In one embodiment,the assay consumable includes at least one assay test site for an assay.A test site can include a plurality of distinct assay domains, at leasttwo of the domains including reagents for measuring different analytes.Still further, the consumable can include a plurality of test sites fora plurality of individual assays. Alternatively, the assay consumablecan be a component that provides a reagent or other assay component thatis used by the system to conduct an assay. For example, the assayconsumable can be a container with one or more compartments for holdingassay reagents. The assay consumable (or test sites therein) can besingle use or it can be reusable. The assay consumable can be configuredto conduct one test or multiple tests (sequentially or in parallel).

Test sites, as used herein, refer to regions of a consumable that hold,contact and/or interrogate a sample. A test site can include a pluralityof distinct assay domains, at least two such domains include reagentsfor measuring different analytes. Consumables can comprise multiple testsites which can hold, contact or otherwise interrogate distinct volumes(aliquots) of the same sample and/or volumes of different samples. Asector of an assay consumable refers to grouping of two or more testsites of the consumable. Each test site can be used to conduct a singlemeasurement or multiple measurements on a volume of sample (for example,the measurement of multiple different analytes in a multiplexed assayformat). Depending on the specific requirements of an application, aconsumable with multiple test sites can be configured to use all of itstest sites in parallel, to use its test sites at different times (e.g.,assigning unused test sites to be used as new samples are delivered tothe assay system), or a combination of both modes of operation can beenabled.

The assay consumable can be any structure useful in diagnosticapplications and that structure can be dictated by the particular assayformat or detection method employed by the device. Examples of assayconsumables suitable for use with the invention include, but are notlimited to, test tubes, cuvettes, flow cells, assay cartridges andcassettes (which can include integrated fluidics for assay processing),multi-well plates, slides, assay chips, lateral flow devices (e.g.,strip tests), flow-through devices (e.g., dot blots), pipette tips,solid phase supports for biological reagents and the like. In certainembodiments, test sites in the assay consumable are defined bycompartments in the assay consumable, e.g., wells, chambers, channels,flow cells and the like. The assay consumable and/or test sites caninclude one or more components used to carry out an assay measurementaccording to one or more specific detection methodologies. Depending onthe function of the consumable and the detection modalities employed bythe assays system, examples of such components can include, but are notlimited to, lateral flow matrices, filtration matrices, optical windows,sensors (e.g., electrochemical and optical sensors), solid phasesupports for binding reactions (e.g., coated slides, chips, beads, pins,coated filtration or lateral flow matrices, tubes and the like),reagents (dry or in liquid form), electrodes, analyte selectivemembranes and the like.

In one embodiment, the assay consumable can be a device thatincorporates a conventional lateral flow test strip, e.g., animmunoassay test strip, as an assay medium. In this example, the deviceis molded to include an identifier or the identifier is affixed to thedevice without any modification to the structure of the device and/orthe assay medium. In one embodiment, the device is placed within theanalytical system, i.e., the assay system, for analysis and before,during or after the performance of the assay, the identifier controllerwithin, affixed to or associated with the assay system reads the datacontained on the identifier and uses that data in the assay or after theassay is completed by the system.

In another embodiment, the assay consumable and accompanying assaysystem or reader is capable of performing a multiplex assay. A multiplexassay is a type of assay in which multiple measurements are performed ona single sample, e.g., by distributing samples across multiple testsites and/or by carrying out multiple measurements on volumes of samplesin individual test sites. The multiple measurements can include, but arenot limited to, (i) multiple replicates of a measurement for an analyte;(ii) multiple measurements of a certain analyte (i.e., multiplenon-identical measurements for the same analyte, e.g., measurements thatdiffer in format or in the identity of the assay reagents that areemployed); and/or (iii) measurements of multiple different analytes. Inone specific embodiment, an assay consumable is configured to carry out,in one or more test sites, multiplex measurements that include at leasttwo assays for two different analytes.

The invention is not restricted to specific approaches for conductingmultiplex measurements in a test site and can employ any of the numeroustechniques that have been developed for carrying out multiplexmeasurements. Multiplex measurements that can be used with the inventioninclude, but are not limited to, multiplex measurements (i) that involvethe use of multiple sensors; (ii) that use discrete assay domains on asurface (e.g., an array) that are distinguishable based on location onthe surface; (iii) that involve the use of reagents coated on particlesthat are distinguishable based on a particle property, such as size,shape, color, etc.; (iv) that produce assay signals that aredistinguishable based on optical properties (e.g., absorbance oremission spectrum), (v) that are based on temporal properties of anassay signal (e.g., time, frequency or phase of a signal), and/or (vi)that are based on some other assay characteristic. Accordingly,interpretation of multiplexed assay results can involve the use ofmultiplexing information, such as the identity of the assays carried outin each test site and, within a test site, any assay characteristics(identity of specific sensors, location and identity of assay domains,etc.) that are used to distinguish assays carried out in a test siteand/or that are used to tie a specific assay identity to thecorresponding assay signal.

In one embodiment, an assay test site comprises a plurality of distinctassay domains and each domain comprises one or more reagents formeasuring a different analyte. Multiplexing information, including thelocation, identity, and composition of each assay domain, is used toidentify the assay signal generated at each domain and connect it to adetermination of the presence or amount of the corresponding analyte (aprocess which can include the application of additional consumable datasuch as signal thresholds and/or calibration parameters). Suchmultiplexing information can be provided as consumable data and/orstored to the consumable identifier.

A test site can be configured to carry out a plurality of multiplexedmeasurements (e.g., it can include a plurality of distinct assaydomains, wherein each domain comprises reagents for measuring adifferent analyte). In one embodiment, the assay consumable can includea plurality of test sites. Information regarding the exact configurationof the one or more test sites, assay domains, and/or one or more sectorsin a consumable can be included in the information saved to the assayconsumable identifier and/or provided as consumable data. Thisinformation can include the location and identity of the test sites,assay domains, and/or one or more sectors as well as multiplexinginformation (as described above) including the number, identity anddifferentiating characteristics of the individual measurements within atest site, assay domain, and/or sector (e.g., the specific locations,identities and/or assay reagents of assay domains within each testsite). In addition, the use of a test site, assay domain, and/or sectorin an assay consumable can also be recorded to the identifier to trackthe use of the consumable in an assay system. The identifier and/orconsumable data can also include information concerning the assay formatand specific processing steps to be used for an assay consumable or testsite, assay domain, and/or sector of an assay consumable. The identifierand/or consumable data can also include information concerninganalytical methods that should be applied by the system once an assay isconducted to analyze the output of an assay in a given test site, assaydomain, and/or sector and, optionally, to provide results that combinethe output from multiple assays in a test site, assay domain, and/orsectors.

The test sites can be configured in any suitable configuration,depending on the geometry of the consumable and/or the type of assayconducted with the consumable. In one embodiment, the test sites areconfigured as wells and/or chambers in the assay consumable. Forexample, the assay consumable of the present invention can be amulti-well plate (e.g., a 24-, 96-, 384- or 1536-well plate), and thewells of the plate can further comprise a plurality (e.g., 2 or more, 4or more, 7 or more, 25 or more, 64 or more, 100 or more, etc.) ofdistinct assay domains. Multi-domain multi-well plates that are adaptedto allow assay measurements to be conducted using electrode inducedluminescence measurements (e.g., electrochemiluminescence measurements)are described in U.S. application Ser. No. 10/238,391, entitled “Methodsand Reader for Conducting Multiple Measurements on a Sample”, filed onSep. 10, 2002, hereby incorporated by reference. The exact configurationof the domains, test sites, and/or sectors in an assay consumable, aswell as the specific identity of each domain, test site, and/or sectorand the reagents bound to that domain/test site/sector can be includedin the information saved to the assay consumable identifier and/orprovided as consumable data. In addition, the use of a given domain,test site, and/or sector in an assay consumable can also be recorded tothe identifier to track the use of the consumable in an assay system.

Assay consumables can be used in a plurality of diverse assays and thisdiversity leads to a variety of suitable configurations of theassociated consumable. In one assay format, the same analyte is measuredat different assay domains within a test site, the different assaydomains being designed to measure a different property or activity ofthe analyte. Information concerning the assay format that can be used inan assay consumable, test site and/or assay domain can also be saved tothe assay consumable identifier and/or provided as consumable data. Theidentifier and/or consumable data can also include informationconcerning analytical methods that should be applied by the system oncean assay is conducted to analyze the output of an assay in a given testsite and/or domain and compare that output to an assay in a separatetest site and/or domain.

One example of a multiplex assay consumable and reader is described inU.S. 2004/0022677, the disclosure of which is incorporated herein byreference in its entirety. Such assay consumables include one or more,and in one embodiment, a plurality of test sites and/or assay domainsfor conducting one or more assay measurements simultaneously orsequentially. For example, the test sites can be configured as wellsand/or chambers. These test sites and/or assay domains comprise one ormore electrodes for inducing luminescence from materials in the testsites and/or assay domains. The assay consumables can further compriseassay reagents in liquid or dry form, e.g., in the test sites, e.g.,wells or chambers, of the consumable.

In addition to the test sites and assay domains, an assay consumable ormulti-well assay plate can include several additional elements, e.g., aplate top, plate bottom, wells, working electrodes, counter electrodes,reference electrodes, dielectric materials, electrical connections, andassay reagents. The wells of the plate can be defined by holes oropenings in the plate top, or as indentations or dimples on a surface ofa plate. The plates can have any number of wells of any size or shape,arranged in any pattern or configuration and can be composed of avariety of different materials. Exemplary embodiments of consumablesthat can be used in the present invention include industry standardformats for the number, size, shape and configuration of the plate andwells, e.g., 96-, 384-, and 1536-well plates, with the wells configuredin two-dimensional arrays. Other formats can include single well plates,2-well plates, 6-well plates, 24-well plates, and 6144-well plates.Multi-well assay plates can be used once or can be used multiple timesand are well suited to applications where the plates are disposable.Various configurations for suitable assay plates can be used in thepresent invention, including but not limited to those depicted in FIGS.11A, 12A, 13A, 13B, 14A, 15, and 16A of U.S. Application Ser. No.2004/0022677, each of which are incorporated herein by reference. Asstated above, the specific configuration and identity of assay testsites, domains, and/or sectors of an assay consumable can be included inthe information saved to the assay consumable identifier and/or providedas consumable data.

In this embodiment, the assay consumables can be used in a reader thatcan be used to induce and measure luminescence, e.g., electrode inducedluminescence or electrochemiluminescence, in assays conducted in or onassay consumables, e.g., multi-well assay plates. The accompanying assaysystem can also induce and/or measure current and/or voltage, forexample, at an electrode. The assay system can incorporate, for example,one or more photodetectors; a light tight enclosure; mechanisms totransport the assay plates into and out of the reader (and inparticular, into and out of a light tight enclosure); mechanisms toalign and orient the assay plates with the photodetector(s) and/or withelectrical contacts; additional mechanisms to track and identify plates(e.g. bar code readers); mechanisms to make electrical connections toplates, one or more sources of electrical energy for inducingluminescence, and appropriate devices, electronics and/or software. Theassay reader can also include mechanisms to store, stack, move and/ordistribute one or more multi-well assay plates (e.g. plate stackersand/or plate conveyors). The assay system can be configured to measurelight from multi-well assay plates by measuring light sequentially froma plurality of sectors or regions of the plate (i.e., a grouping of aplurality of adjacent assay domains within a plate) and/or from theentire plate substantially simultaneously or simultaneously. The assaysystem can also incorporate additional microprocessors and computers tocontrol certain functions within the system and to aid in the storage,analysis and presentation of data. Various configurations for suitableassay systems can be used in the present invention, including but notlimited to those depicted in FIGS. 17 to 23 of U.S. Application Ser. No.2004/0022677, each of which are incorporated herein by reference.

The additional microprocessors and computers in the assay system canalso interact with the assay consumable identifier microprocessor orcontrollers by transferring data and commands to/from the identifier tothe various microprocessors/controllers throughout the system to performvarious operations of the components listed above within the assaysystem.

The system can adjust the assay parameters prior to initiating an assaybased on the consumable data saved to the identifier and/or stored orprovided as consumable data via a direct or indirect interface.Thereafter, the system makes the appropriate electrical, fluidic and/oroptical connections to the consumable (making use of electrical, fluidicand/or optical connectors on the consumable and system) and conducts anassay using the consumable. The sample can be introduced into theconsumable prior to inserting the consumable in the system.Alternatively, the sample is introduced by a component of the systemafter the consumable is inserted in the system. The assay can alsoinvolve adding one or more assay reagents to the consumable andinstructions for adding those various assay reagents can be saved to theidentifier and/or provided as consumable data and the system adds thosereagents to the consumable before or during the assay according to theinstructions saved to the assay consumable identifier and/or provided asconsumable data.

Alternatively, the assay consumable is a cartridge and the consumablefurther comprises an element selected from one or more fluidiccomponents, one or more detection components, one or more assay cells,reagents for carrying out an assay, working electrodes, counterelectrodes, reference electrodes, dielectric materials, electricalconnections, dried and/or liquid assay reagents, or combinationsthereof. The cartridge can further comprise at least one assay cell thatcomprises a plurality of distinct assay test sites and/or domains, eachof these test sites and/or domains comprising reagents for measuring adifferent analyte.

An example of an assay consumable cartridge that can be used in thepresent invention is described in US Application Ser. No. 2004/0189311,the disclosure of which is incorporated herein by reference in itsentirety. The assay consumable described therein is an assay cartridgethat incorporates one or more fluidic components such as compartments,wells, chambers, fluidic conduits, fluid ports/vents, valves, and thelike and/or one or more detection components such as electrodes,electrode contacts, sensors (e.g. electrochemical sensors, fluidsensors, mass sensors, optical sensors, capacitive sensors, impedancesensors, optical waveguides, etc.), detection windows (e.g. windowsconfigured to allow optical measurements on samples in the cartridgesuch as measurements of absorbance, light scattering, light refraction,light reflection, fluorescence, phosphorescence, chemiluminescence,electrochemiluminescence, etc.), and the like. Such consumables can alsocomprise reagents for carrying out an assay such as binding reagents,detectable labels, sample processing reagents, wash solutions, buffers,etc. The reagents can be present in liquid form, solid form and/orimmobilized on the surface of solid phase supports present in thecartridge. In this embodiment, the consumables include all thecomponents necessary for carrying out an assay. In addition, the assayconsumable is used in connection with a consumable reader adapted toreceive the consumable and carry out certain operations on theconsumable such as controlling fluid movement, supplying power,conducting physical measurements on the cartridge, and the like.

More specifically, such assay consumable cartridges have one or moreassay test sites (e.g., wells, compartments, chambers, conduits, flowcells, etc.) that can include one or more assay domains (e.g., discretelocations on an assay test site surface where an assay reaction occursand/or where an assay dependent signal, such as an electrochemical or anelectrode induced luminescence signal is induced) for carrying out aplurality of assay measurements. In this embodiment, assay domains aresupported on assay electrodes (in one embodiment, an array of assayelectrodes, e.g., a one dimensional array of assay electrodes) so as topermit the conduct of assays based on electrochemical or electrodeinduced luminescence measurements. The assay domains are, optionally,defined by a dielectric layer deposited on the electrodes. In addition,the assay consumables can have one or more attributes that make themsuitable for use in “point of care” clinical measurements, e.g., smallsize, low cost, disposability, multiplexed detection, ease of use, etc.

The assay consumable cartridge can comprise the necessary electroniccomponents and/or active mechanical components for carrying out an assaymeasurement, e.g., one or more sources of electrical energy, ammeters,potentiometers, light detectors, temperature monitors or controllers,pumps, valves, etc. Alternatively, some or all of the electronic and/oractive mechanical components are arranged within a separate assayreader. The reader would also have the appropriate electrical, fluidicand/or optical connections to the assay consumable for carrying out anassay using the consumable. Using such an arrangement, the assayconsumable can be designed to be low cost and disposable while thereader (which holds the more expensive and complex components) isreusable.

In one embodiment, a cartridge-based biochemical detection system caninclude a system housing comprising an optical detector wherein thesystem housing is adapted and configured to receive and position theassay consumable and/or the optical detector for processing. The systemcan further comprise support subsystems that can include one or more ofthe following: storage subsystem for storing assay reagents/consumablesand/or waste; sample acquisition/preprocessing/storage subsystem forsample handling; fluidic handling subsystem for handling the reagents,sample, waste, etc. and for providing fluids to the detection chambervia a fluid inlet line; electrical subsystem for electrically contactingthe cartridge's electrical contacts and supplying electrical energy tothe electrodes; and a control subsystem for controlling and coordinatingoperation of the system and subsystems and for acquiring, processing andstoring the optical detection signal. The information stored to theassay consumable identifier and/or provided as consumable data caninclude information that is used to control or adjust one or more of theassay system components prior to and/or during the conduct of an assayusing the assay consumable.

Still further, the assay consumable can be a container holding one ormore assay reagents, including but not limited to one or more buffers,diluents, and/or reagents used by the assay system in the conduct of anassay. The assay consumable identifier can be affixed to the containerand/or affixed to a packaging for the container.

Assay Consumable Identifier

In one embodiment, the assay consumable identifier comprises memory forstoring information related to the consumable, its history and/or itsuse. In one embodiment, the memory is non-volatile memory. Non-volatilememory is computer memory that can retain the stored information withoutpower. Examples of non-volatile memory which can be used in theconsumable identifier include, but are not limited to, electronicnon-volatile memory (e.g., read-only memory and flash memory), magneticmemory (e.g., hard disks, floppy disk drives, and magnetic tape),optical memory (optical disc drives) and hybrids of these approaches(e.g., magneto-optical memory).

In one embodiment, the assay consumable identifier comprises EPROM(erasable programmable read-only memory), a type of programmableread-only memory that can be erased by exposing it to ultraviolet light.Once erased, it can be reprogrammed with new or modified data. Inanother embodiment, the assay consumable identifier comprises EEPROM(electronically erasable programmable read-only memory) a class ofnon-volatile electronic memory that can be electrically erased andreprogrammed without exposure to UV light. An EEPROM can be written toor programmed more than once and can be selectively programmed (thecustomer can alter the value of certain cells without erasing theprogramming of the other cells). Therefore, sections of data can beerased and replaced without needing to alter or reinstall the rest ofthe chip's programming.

In another embodiment, the assay consumable identifier comprises flashmemory, a specific type of EEPROM that is erased and programmed in largeblocks. Although flash memory is technically a type of EEPROM, the term“EEPROM” is generally used to refer specifically to non-flash EEPROMwhich is erasable in small blocks, typically bytes. Because erase cyclesare slow, the large block sizes used in flash memory erasing give it asignificant speed advantage over conventional EEPROM when writing largeamounts of data.

In another embodiment, the assay consumable identifier comprises a smartcard, chip card, or integrated circuit card (ICC) (referred tocollectively as “ICCs”). These are small cards with embedded integratedcircuits which can process and store data. There are two broadcategories of ICCs; i) “memory cards” that contain non-volatile memorystorage components and, optionally, some specific security logic but donot contain microprocessors and Ii) “microprocessor cards” that combinenon-volatile memory components with microprocessor components and enablethe processing of information being read into or out of the ICC. The ICCelectronic components are supported on a card that is, typically, madeof plastic such as PVC or ABS. The card can include an embedded hologramto avoid counterfeiting. Contact ICCs have conductive contact pads. Wheninserted into a reader, the contact pads on the ICC make contact withelectrical connectors in the reader to allow for transfer of informationbetween the reader and the ICC, for example, allowing the reader toread, erase or write information on the ICC..

Another method of transferring information is via an RFID, i.e., radiofrequency identification, which is similar in theory to bar codeidentification. With RFID, the electromagnetic or electrostatic couplingin the RF portion of the electromagnetic spectrum is used to transmitsignals. An RFID system consists of an antenna and a transceiver, whichread the radio frequency and transfers the information to a processingdevice, and a transponder, or tag, which is an integrated circuitcontaining the RF circuitry and information to be transmitted.

Identification can also be accomplished by reading a bar code. One ofthe key differences between RFID and bar code technology is that RFIDeliminates the need for line-of-sight reading that bar coding dependson. Also, RFID scanning can be done at greater distances than bar codescanning. High frequency RFID systems (850 MHz to 950 MHz and 2.4 GHz to2.5 GHz) offer transmission ranges of more than 90 feet, althoughwavelengths in the 2.4 GHz range are absorbed by water (the human body)and therefore has limitations.

In one embodiment, the non-volatile memory used in the present inventionis comprising an EEPROM, flash memory, ICC or combinations thereof. Inone embodiment, the non-volatile memory is an EEPROM. In an alternateembodiment, the non-volatile memory is an RFID.

In an additional alternative embodiment, two or more non-volatile memorycomponents can be used in the present invention. For example, a firstassay consumable comprising a first identifier can be used in the assaysystem, and an additional assay consumable comprising an additionalidentifier can also be used in the assay system. Each identifier caninclude the same or different type of memory. However, for eachdifferent form of memory, there will be a separate identifiercontroller. And certain consumable data can be stored on one identifierand other consumable data on an additional identifier of the same ordifferent type. For example, one assay consumable used in the system cancomprise an EEPROM or RFID as an identifier, whereas the system can alsouse an additional assay consumable comprising, e.g., a bar code as anidentifier. The assay system would comprise an identifier controllercapable of interfacing with the first identifier, i.e., the EEPROM orRFID, and the system will further comprise an additional controller thatwill interface with the bar code.

The assay system of the present invention includes an identifiercontroller that controls the operation of the non-volatile memory andother components of the assay system. The identifier controlleroptionally includes a micro-controller to interface with thenon-volatile memory over a communication interface, which canincorporate conventional interface architectures and protocols such asI²C, a two line serial bus protocol. The microcontroller addresses thenon-volatile memory and performs write, read and erase operations on thememory.

The consumable identifier can be located on the consumable or it can bea separate component. In either case, the system can be designed to havea unique identifier for each consumable. Alternatively, the system canbe configured so that one separate consumable identifier is used to holdinformation relating to a plurality of consumables. In one example, eachpackage of consumables has a package-specific identifier mounted on thepackage (or, alternatively, supplied in the package) that holdsinformation relating to the plurality of consumables in the package.Optionally, each consumable also carries an additional uniqueconsumable-specific identifier attached to the consumable. Thisconsumable-specific identifier is used primarily to uniquely identifythe consumable and link it to information on the package-specificidentifier. In this embodiment, lot information content and/ornon-editable identifiers such as bar codes can be used.

The various components of the assay system can be housed together in asingle unit or can be housed separately. For example, the assay systemcan include an assay reader and an identifier controller as separateunits. The assay system provides for communication (which can be wiredor wireless communication) directly between the assay reader andidentifier controller or, alternately, indirectly through additionalcomponents of the assay system. In an alternative embodiment, theidentifier controller is housed within the assay reader. In such anembodiment, the assay reader can be configured such that insertion ofthe consumable into the reader during the conduct of an assay alsoenables communication between the consumable identifier and theidentifier controller (e.g., a port into which the consumable isinserted includes components for processing and/or reading theconsumable and also includes components, such as electrical contacts ora radio transmitter, for communicating with the consumable identifier).In one example, when the consumable is loaded into the assay system,electrical contacts are made between the controller and the identifier,e.g., non-volatile memory. The controller is then able to read, eraseand/or write consumable data to the identifier. Alternatively, the assayreader can have separate ports for processing/reading a cartridge andfor communicating with the consumable identifier. The customer placesthe assay consumable or packaging in or in proximity to the controllerport such that the controller makes electrical contact with theidentifier to enable the controller to read, erase and/or writeconsumable data to the non-volatile memory.

In one embodiment, the identifier comprises non-volatile memorycomprising an RFID tag, a bar code, an EPROM, and EEPROM. Still further,the identifier can comprise an EEPROM comprising flash memory and ICC.

The methodologies of the present disclosure may be provided and/orimplemented on one or more processors, and for example, also may beprovided via web-based and/or cloud computing framework.

A computer readable medium may include any tangible device that canstore a computer code or instruction that can be read and executed by acomputer or a machine. Examples of computer readable medium may include,but not limited to, hard disk, diskette, memory devices such as randomaccess memory (RAM), read-only memory (ROM), optical storage device, andother recording or storage media.

Consumable Data

The identifier is programmed, e.g., during the manufacturing process orwhen the consumable is prepared for shipment. The identifier can beprogrammed with consumable data which can be used before, during orafter an assay or a step of a multi-step assay to control the operationof the assay system, reader or a component of the assay system. Inaddition or alternatively, some or all of the information required foruse of a given consumable can be provided as consumable data. The term“consumable data” can include any information used to uniquely identifya particular assay or assay step, assay consumable, consumabledomain(s), biological reagent or sample or to distinguish a particularassay, assay step, assay consumable, consumable domain(s), biologicalreagent or sample from other assay consumables, consumable domains,biological reagents or samples. Consumable data can include consumableinformation, sample information, chain of custody information,consumable/test site information, assay process information, consumablesecurity information, or combinations thereof. Consumable data canfurther include information related to one or more analytical tools thatcan be applied by the system to analyze data generated during and/orafter the conduct of an assay, assay system maintenance information,system-consumable promotional information, and/or system and/orconsumable technical support information.

Each type of consumable data is described in more detail below and itshould be understood that each type of consumable data can be stored tothe consumable identifier and/or provided as consumable data.

Consumable Identification & Configuration Information

Consumable data can include consumable identification and configurationinformation that includes but is not limited to lot identificationinformation, lot specific analysis parameters, manufacturing processinformation, raw materials information, expiration date, Material SafetyData Sheet (MSDS) information, product insert information (i.e., anyinformation that might be included or described in a product insert thatwould accompany the assay consumable, e.g., the assay type, how theassay is performed, directions for use of the assay consumable, assayreagents, or both, etc.), threshold and/or calibration data for one ormore reagents used in the assay consumable or in an assay or a step of amulti-step assay, and the location of individual assay reagents and/orsamples within one or more test sites of the assay consumable.

The consumable data can also include lot identification information,i.e., information that is used to identify a particular lot of assayconsumables, which is distinct from lot-specific analysis parameters,which includes that information that is unique to a given lot that canbe used by the system, e.g., to conduct an assay with a consumable fromthat lot or to analyze assay results derived from a consumable from thatlot. In one embodiment, if the assay consumable is a multi-well assayplate or a cartridge, the lot-specific analysis parameters can include,but are not limited to, the following: (i) the revision level thatdetermines the schema used to interpret the information; (ii) theconsumable type; (iii) the date of manufacture; (iv) the lot number; (v)the date of expiration; (vi) a cross-talk correction matrix, to accountfor chemical cross-reactivity; (vii) a threshold for assays to beconducted in the consumable and each internal negative control; (viii) arange for each internal positive control; (ix) ranges for each assay tobe conducted in the cartridge for the positive control sample; (x) asoftware checksum to ensure integrity of the data; (xi) in-well (orin-test site) control acceptance ranges; (xii) assay names and/oridentifiers; (xiii) information concerning assay quality control,including negative and positive quality control materials that are usedto verify the operation of the reader and the consumable; (xiv)calibration information such as a master calibration curve; and (xv)number and names of assay calibrators and/or assay calibrator acceptanceranges.

The consumable data can include sample information, such as the locationof samples within at least one test site of the assay consumable, assayresults obtained on the assay consumable for the sample, and theidentify of samples that have been and/or will be assay in the assayconsumable

The consumable data can also relate to chain of custody, e.g.,information regarding the control, transfer and/or analysis of thesample and/or an assay consumable. Chain of custody information can beselected from customer identification, sample identification, time anddate stamp for an assay, the location of the assay system in alaboratory during the assay, calibration and QC (quality control) statusof the assay system during the assay, custody and/or locationinformation for the assay consumable before and after the conduct of theassay, assay results for a given sample, as well as customer createdfree text comments input before, during or after an assay is processedby the system. Still further, chain of custody information can includetime, date, manufacturing personnel or processing parameters for one ormore steps during the manufacture of the assay consumable, custody,location and/or storage conditions for the assay consumable followingmanufacture and/or between steps during the manufacture of the assayconsumable.

Consumable data can also include consumable/test site information, suchas consumable type and structure, the location and identity (e.g., thestructure, composition, sequence, concentration and/or origin) of assayreagents included within an assay consumable, and the location andidentity of assay reagents within an assay test site of the assayconsumable. The consumable data can be used to distinguish a first testsite within that consumable from a different test site within theconsumable. Still further, the consumable data can include sampleinformation comprising the location of samples within at least one testsite of the assay consumable; assay results obtained on the assayconsumable for the sample; identity of samples that have been and/orwill be assayed in the assay consumable; or combinations thereof.Additionally, the consumable data is consumable/test site informationcomprising consumable type and structure; location and identity of assayreagents included with the assay consumable; location and identity ofassay reagents within an assay test site of the assay consumable; orcombinations thereof

In an additional embodiment, consumable/test site information caninclude information concerning assays previously performed by a readeron one or more test sites of the consumable, and information concerningassays to be performed by a reader on one or more test sites within theconsumable. Therefore, once the assay is conducted by the system, thecontroller can be used to write the results of the assay to theidentifier. Such information includes, but is not limited to raw oranalyzed data collected by the system during the assay (wherein analyzeddata is data that has been subjected to statistical analysis aftercollection and raw data is data that has not been subjected to suchstatistical analysis), a list of test sites and/or domains within theassay consumable used during a given assay, a schedule of events to beconducted on an assay consumable or a test site and/or domain within anassay consumable, a list of those test sites and/or domains of the assaydevice that have not be subjected to an assay, assay or system errorsthat resulted during a given assay or assay step, or combinationsthereof.

Still further, consumable data can be used as a security mechanism,e.g., to confirm that the correct assay consumable is being used in thesystem (referred to herein as “consumable security information”). Theconsumable data can include a digital signature to prove that theconsumable was manufactured by the designated vendor. In one embodiment,if an inappropriate assay consumable is present in the system, e.g., acounterfeit consumable or a consumable that is otherwise incompatiblewith the assay system, the controller will disable the system, reader ora component thereof. In addition or alternatively, the consumable datacan be used to detect the proper placement of the assay consumable inthe system, e.g., the proper orientation of the assay consumable or aportion thereof, in the assay system, such that the controller willdisable the system, reader or a component thereof until the assayconsumable is placed in the correct orientation. Still further, theconsumable data can also be used to detect a defect in the assayconsumable or an assay test site and/or domain and the controller willdisable the system, reader or a component thereof accordingly. Forexample, depending on the nature of the defect in the assay consumableor domain, the controller can disallow the use of the assay consumablein its entirety or direct the reader to disallow the use of a test siteand/or domain or a set of test site and/or domain in the assayconsumable. In one embodiment, the reader can perform a diagnosticanalysis on the assay consumable and/or a test site and/or domaintherein to identify defects therein and the controller will write theresults of that diagnostic analysis to the identifier on the consumable.If the consumable is later used in a different reader, the results ofthis diagnostic analysis will be read by the controller and used by thereader to adjust the use of that consumable or a test site and/or domainin that consumable accordingly. In a further embodiment, the assayconsumable can be subjected to a quality control process during or afterits manufacture and the results of that quality control analysis can bewritten to the identifier for later use and/or verification by thecustomer of the assay consumable in an assay reader.

The consumable data can also include authorization information forconsumables or test site and/or domain thereof or biological reagents,such as information regarding whether a particular customer has a validlicense to use a particular consumable or biological reagent, includingthe number of times the customer is permitted to use the particularconsumable or biological reagent in a particular assay and thelimitations, if any, on that use, e.g., whether the customer's licenseis for research purposes only. Such information can also includevalidation information regarding whether a particular consumable orbiological reagent has been subject to a recall or has otherwise becomeunsuitable or unauthorized for use. The recall information and anoptional last recall check date and/or timestamp can be written to theidentifier and/or provided as consumable data.

The consumable data can further include information regarding the originof a biological reagent used in an assay consumable, test site and/ordomain, including for example an identification of an original samplefrom which it was derived or the number of generations removed it isfrom an original sample. For example, if an assay reagent used in anassay is an antibody, the consumable data can include the identificationof the hybridoma from which the antibody was derived, e.g., the ATCCaccession number for that hybridoma.

According to various embodiments, biological samples or reagents thatare provided in or with the consumables described above can be licensedseparately from systems designed to operate on the biological reagents.In various embodiments the assay system, reader or a component thereofis coupled to a network that allows the system to communicate overpublic and/or private networks with computer systems that are operatedby or on behalf of the customers, manufacturers and/or licensors of thebiological reagents, consumables or systems. In various embodiments, alimited license can provide for the use of licensed biological reagents,consumables or systems for a particular biological analysis on onlylicensed systems. Accordingly, a system can authenticate a biologicalreagent, consumable or system based on, for example, a digital signaturecontained in the identifier associated with a particular consumableand/or provided as consumable data, if a particular customer has a validlicense. In various embodiments, the identifier and/or consumable datacan also be used to provide for a one time use such that biologicalreagents cannot be refilled for use with the same authentication.

In certain embodiments, when the identifier is read by a system, readeror component thereof that has access to a public or private data networkoperated by or on behalf of the customers, manufacturers and/orlicensors of the biological reagents, consumables or systems, certainconsumable data can be communicated to the assay system and read,written or erased locally via the identifier/controller on the assaysystem. For example, recall and/or license information can be a subsetof consumable data that is available via a direct and/or indirectinterface, whereas additional consumable data e.g., lot-specific,expiration date, calibration data, consumable specific information,assay domain information, assay results information, consumable securityinformation, or combinations thereof, can be stored locally on theidentifier and otherwise unavailable via the network connections on theassay system. In one embodiment, recall, license and/or consumablesecurity information can be available via the network connections on theassay system and/or stored to the storage medium as consumable data andthe remaining consumable data is stored locally on the identifier. Theassay system or reader includes system hardware, system firmware, systemdata acquisition and control software, and method or consumable data. Invarious embodiments, the system hardware includes electronic control anddata processing circuitry, such as a microprocessor or microcontroller,memory, and non-volatile storage. In various embodiments, the systemhardware also includes physical devices to manipulate biologicalreagents such as robotics and sample pumps. In various embodiments, thesystem firmware includes low-level, computer-readable instructions forcarrying out basic operations in connection with the system hardware. Invarious embodiments, the system firmware includes microprocessorinstructions for initializing operations on a microprocessor in thesystem hardware.

The system data acquisition and control software is higher-levelsoftware that interfaces with the system firmware to control the systemhardware for more specific operations such as operating a charge coupleddevice (CCD) to acquire visual luminescence information regarding aparticular biological analysis. In various embodiments the dataacquisition and control software includes a software-implemented statemachine providing, for example, the following states: (i) idle; (ii)running; (iii) paused; and (iv) error. In various embodiments, when thestate machine is in the idle state, it can receive an instruction fromthe general purpose machine to perform a particular data acquisition orsystem control operation. In various embodiments, the general purposecomputer opens a TCP/IP socket connection to the system, determineswhether the system is in the idle state and then begins transmittinginstructions and/or parameters. In various embodiments, an encryptedTCP/IP connection is established, using, for example, the SSH protocol.The instructions and/or parameters can be in the form of ASCII encoded,human readable consumable and/or method information that defines thebehavior of the biological system. In various embodiments, theconsumables and/or methods are stored in the form of ASCII text files.In various embodiments, the general purpose computer uses the FTPprotocol to transfer the ASCII text files to the system. In variousother embodiments the method and/or consumable information is stored inand read from the identifier. The method and/or consumable informationcan be stored in the form of an ASCII text file in the identifier, butit is understood that the information can be represented in other dataformats without departing from the present teachings.

According to various embodiments, the consumable, macro, and/or methodinformation includes parameters that can be used by the system dataacquisition and control software to perform specific data acquisitionand system control operations. In various embodiments, the method and/orconsumable information contains sequences of operations to be performedby the system or control parameters for use in connection with the dataacquisition or control software.

(ii) Assay Process Information

In addition, the consumable data can include assay process informationconcerning the individual assay parameters that should be applied by thesystem or reader during the assay. For example, such consumable data caninclude a sequence of steps for a given assay, the identity,concentration and/or quantity of assay reagents that should be used oradded during the assay or during a particular step of an assay, e.g.,buffers, diluents, and/or calibrators that should be used in that assay.The consumable data can also include the type or wavelength of lightthat should be applied and/or measured by the system or reader duringthe assay or a particular step of a multi-step assay; the temperaturethat should be applied by the system or reader during the assay; theincubation time for an assay; and statistical or other analyticalmethods that should be applied by the system or reader to the raw datacollected during the assay.

In one embodiment, one or more steps of an assay protocol can betailored to an individual consumable or lot of consumables. One or moresteps of a protocol can differ from consumable lot to lot and/or fromindividual consumable to consumable within a given lot and theconsumable data stored to the system includes instructions to tailorthose steps of the assay protocol. This type of consumable data can beused by the system to adjust one or more operations performed by thesystem before, during and/or after the conduct of an assay by thesystem. Moreover, this type of consumable data can optionally beadjusted by the system user at the user's discretion. For example,dilution steps in an assay protocol can be adjusted to account for lotto lot or consumable to consumable differences. The amount of diluentadded and/or the nature of the diluent can be altered based on suchdifferences. Similarly, the amount of a given reagent that can be addedduring the conduct of an assay, an incubation period and/or temperaturefor one or more steps of an assay can also be dependent on lot to lot orconsumable to consumable differences. Each of these are non-limitingexamples of consumable data that can be saved to the storage medium ofthe system.

Moreover, the consumable data comprises information that directly orindirectly controls a component of the assay system, e.g., one or morephotodetectors, a light tight enclosure; mechanisms to transport theassay consumables into and out of the reader; mechanisms to align andorient the assay consumables with the one or more photodetector(s)and/or with electrical contacts in the reader; additional mechanismsand/or data storage media to track and/or identify assay consumables;one or more sources of electrical energy to induce luminescence;mechanisms to store, stack, move and/or distribute one or moreconsumables; mechanisms to measure light from a consumable during theassay sequentially, substantially simultaneously or simultaneously froma plurality of test sites of the consumable; or combinations thereof.

The consumable data can also include assay process informationcomprising assay parameters to be applied by the reader during theassay; a sequence of steps to be applied by the reader during the assay;the identity, concentration, and/or quantity of assay reagents to beused or added during the assay; the type or wavelength of light to beapplied and/or measured by the reader during the assay; the temperatureto be applied by the reader during the assay; an incubation time for theassay; statistical or analytical methods to be applied by the reader toraw data collected during the assay; or combinations thereof (such assayprocess information can optionally be adjusted by the user). In onespecific embodiment, the assay conducted with the consumable is amulti-step assay and the assay process information relates to a step orstep(s) of the multi-step assay. In this embodiment, the consumable/testsite information comprises information concerning assays previouslyperformed by a reader on one or more test sites of the consumable;information concerning assays to be performed by an assay reader or acomponent thereof on one or more test sites within the consumable; orcombinations thereof.

The consumable data can additionally include information regarding aconsumable, test site, domain, sector, or a biological reagent or sampleas individual operations are performed on that consumable, test site,domain, sector, or biological reagent or sample, for example duringmanufacture of the consumable, test site, domain, sector, or biologicalreagent or while an assay or step is being performed on the consumable,test site, domain, sector, or biological reagent or sample. For example,if an assay consumable includes a plurality of assay test sites,domains, and/or sectors, the assay system can perform an assay or stepof a multi-step assay on a single test site, domain and/or sector of theassay consumable. Once that assay or assay step is completed by theassay system, the controller records the results of that assay, e.g.,the raw or analyzed data generated during the assay or assay step, tothe identifier, and/or the controller records which test site, domainand/or sector of the assay consumable were used during the assay orassay step and/or which test site, domain and/or sector of the assayconsumable have yet to be used. The assay consumable can be stored forlater use and when the customer is ready to use another test site,domain and/or sector of the assay consumable, the controller reads theconsumable data stored on the identifier of the assay consumable toidentify which test site, domain and/or sector has been used, has yet tobe used, and/or the results of those assays. The controller can theninstruct the assay system, reader or component thereof to conduct anassay or assay step on an unused test site, domain and/or sector.

In addition, a given assay protocol can require a set of consumables ofa particular type. Therefore, if the customer inputs a specific type ofassay consumable, e.g., a multi-well assay plate, for use in aparticular assay protocol, one or more additional assay consumables canbe required to carry out that assay protocol in the system, e.g., one ormore reagents can be required for use with that multi-well assay plate.Each of the required consumables can include a consumable identifierwith information concerning the consumable requirements for an assayprotocol. When one of the required consumables is input into the assaysystem and the identifier controller interacts with the consumableidentifier for that consumable, the system will take an inventory of thecomponents present in the system and compare the results to theconsumable requirements stored to the consumable identifier and/orstored to the storage medium and/or provided as consumable data. If anyrequired consumables are not present or are present in insufficientsupply, the system will prompt the customer to input the additionalrequired consumables for that assay protocol based on the informationstored on the required consumable identifier. If two or more assayconsumables are used in the system, the instrument will correctlyidentify a first assay consumable and any associated consumables basedon the consumable requirements stored to the identifiers associated witheach consumable. The system will verify that the assay consumable andassociated consumables are loaded on the system before the sample isrun. In the case where only the first assay consumable is loaded intothe system without the corresponding associated consumable, the systemwill prompt the customer to load the associated consumable if theinstrument does not identify the associated consumable within the systemwithin a predefined period of time. The system will notify the customerif mismatched assay consumables are loaded on the instrument. The systemwill not run samples if there are no available matched sets of assayconsumables (e.g., multi-well assay plates and given reagents for aparticular assay). The system will check for assay consumable expirationprior to the start of an assay and the system will alert the customerand prevent the use of an expired consumable. The system will notprocess a sample if the consumables have expired prior to sampleaspiration. If a partially used assay consumable is installed into adifferent instrument, consumable usage will automatically start with thenext available unused well.

The identifier can also be used to track the time a given assayconsumable is present in the assay system. Therefore, when an assayconsumable is inserted into or contacted with an assay system, a timeris initiated in the assay system and the start time is recorded to theidentifier. When the assay is initiated by the system on the consumableor a test site, domain and/or sector within the consumable, the time isalso recorded to the identifier. If the instrument, system or acomponent thereof is shutdown (e.g., by turning the power off), thetimer is stopped and that time is recorded to the identifier. Thus,whenever the timer is stopped, the accumulated onboard time is recordedto the identifier.

(iii) Analytical Tools

In another embodiment, the consumable data further includes one or moreanalytical tools that can be applied by the system to analyze datagenerated during and/or after the conduct of an assay. In addition, suchanalytical tools can include instructions for the customer and/or thesystem to generate a specific output by the system software after theconduct of an assay, e.g., a tailored data report and/or format for theresults of the analysis based on the consumable data. Alternatively oradditionally, the analytical tools can further include one or morestatistical algorithms that can be applied by the system to the data.For example, the consumable data can include a selection of two or morestatistical algorithms that can be used to analyze data resulting fromuse of a given consumable and the customer can optionally select theappropriate algorithm for the desired data analysis. The consumable datacan also include information that can be used by the customer to selectthe appropriate algorithm for his or her needs, e.g., technical notes orliterature references related to algorithm selection.

Analytical tools can differ from consumable lot to lot and/or fromindividual consumable to consumable within a given lot. In thisembodiment, the consumable data is used by the system to adjust theanalytical processing tools applied by the system software in theconduct of an assay or after the assay is completed and the results aregenerated and/or displayed. Such analytical processing tools include butare not limited to assay thresholds and/or calibration curves that canbe applied to one or more steps of an assay protocol that can also bealtered based on consumable differences. In a specific embodiment, for agiven consumable type and/or desired use, the consumable data caninclude a project management tool that schedules the conduct of one ormore assays or steps thereof using a given consumable in the system orwith a set of consumables. Still further, such analytical processingtools can optionally be adjusted by the system user at the user'sdiscretion. Analytical tools can be sent to the customer via a direct orindirect interface between the system and the customer.

(iv) Assay System Maintenance Information

Consumable data can further comprise system maintenance information tothe customer, including but not limited to system monitoring reports,system components usage, service history, system troubleshootinginformation, the results of diagnostics run on the system, controlcharting, periodic maintenance scheduling, warranty informationregarding the system and/or components thereof, or combinations thereof.The system software can be programmed to monitor various components ofthe system and automatically or when prompted, send monitoring reportsto a remote computing system and/or to a service technician. If a directinterface is not enabled, the system can prompt the customer to sendmonitoring reports to the CD server via an indirect interface. Inaddition or alternatively, such system monitoring reports can beaccessed by a service technician charged with the task of maintainingand/or servicing the system on site or remotely. In this embodiment, aservice technician can communicate with a customer regarding service ofor assistance with an instrument via a direct or indirect interface. Ina specific embodiment in which a direct interface is enabled, the CDserver monitors system component usage and/or warranty information andbased on standard system component lifetimes and/or warranty terms,schedules periodic system/component maintenance and/or upgrades by aservice technician. However, the system can be programmed toautomatically monitor such information on the system and it canperiodically prompt the customer to send the CD server the output ofsuch monitoring activities via an indirect interface if a directinterface is not enabled to enable a service technician to assess thestatus of the system and to determine if system service or maintenanceis required. In addition, the CD server can maintain a log of theservice history for a given assay system and schedule a service call bya service technician (this can be done using either a direct or indirectinterface). The remote computing system can also send an individualassay system software upgrades via a direct or indirect interface.

(v) System-Consumable Promotional Information

In another embodiment, consumable data includes promotional materials,e.g., when a new type or lot of consumables becomes available,especially those products historically used by a given customer. Suchpromotional materials can also relate to new assay systems,modifications to a current system, and/or optional attachments orimprovements to a current system, especially those modifications,attachments or improvements that specifically relate to a system thecustomer owns or operates and/or those modifications, attachments orimprovements that might be of interest to the customer based on thatcustomer's prior usage. Consumable data of this type can also includeliterature references, brochures, product inserts, technical andapplication notes, technical presentations, conference information, andpromotional seminars, especially those that can relate to one or moreconsumables/systems used by a given customer. Such promotionalinformation can be provided to the customer via a direct or indirectinterface between the customer and vendor.

(vi) Technical Support Information

Consumable data also includes technical support information that canassist the customer in the use of a consumable or system, e.g., productinsert and data sheet information, information relates to associatedproducts intended to be used with that consumable, instructions for use,training materials, tutorials, recommended usage and/or storageinformation, data analysis templates, template reports, calibrationcurves, lot specific QC data, verified limits of quantitation, andtrouble-shooting methods and/or algorithms. For consumables that includeor are provided with one or more additional consumables, e.g., reagents,the consumable data can also include a reagent catalog number, reagentlot specific information, reagent manufacture dates, reagent expirationdates, instructions for use, training materials, tutorials, recommendedusage and/or storage, and the like. Technical support information canalso include receiving feedback or assistance via a direct or indirectinterface with a technical support representative, e.g., customertraining modules, consulting services, and/or live customer serviceassistance capabilities to facilitate the customer experience (i.e.,live-chatting). It will be understood that technical support informationcan relate to a consumable, system, or both.

In a specific embodiment, Table 1 includes a list of consumable datathat can be stored to a consumable identifier and/or exchanged between aCD server and a system via a direct or indirect interface.

TABLE 1 Types of Consumable Data Examples of Consumable Data ConsumableConsumable type identification and/or Consumabledescription/configuration configuration information Consumable lotnumber Consumable expiration date Certificate of analysis Lot specificquality control data Catalog number Associated consumables Verifiedlimits of quantitation shipping manifest for complete order recommendedstorage conditions product insert chain of custody information Assayprotocol steps Instructions for use in the system Analytical tools thatcan Data analysis templates be applied by the system Report templatesCalibration curves Statistical analyses that can be applied to a dataset Assay thresholds Project management scheduler Assay systemPreventative maintenance tips & reminders for system or componentsthereof maintenance information Service reminders & scheduling forservice visits Warranty information for system or components thereofSystem software upgrades/patches Service history information Individualsystem component monitoring and remote maintenance System-consumable Newconsumable and/or system offerings promotional information Literaturereferences that relate to customer-system use System and/or Productinsert consumable technical Training materials support informationAccess to customer support representatives Usage recommendations, e.g.,sample type and sample preparation procedures Recommended usageconfiguration Trouble shooting algorithms Concentration ranges forcontrols Expected calibration curve data for consumable Recommendedcalibration curve concentrations for consumable

The present invention is not to be limited in scope by the specificembodiments described herein. Indeed, various modifications of theinvention in addition to those described herein will become apparent tothose skilled in the art from the foregoing description and accompanyingfigures. Such modifications are intended to fall within the scope of theclaims. Various publications, including U.S. application Ser. No.12/844,345, filed Jul. 27, 2010, are cited herein, the disclosures ofwhich are incorporated by reference in their entireties.

What is claimed is:
 1. A method of controlling customer access to an assay system, said method comprising the steps of: (a) receiving a system identifier; (b) identifying said system identifier; and (c) utilizing information obtained from the system identifier to perform one or more operations selected from: (i) enabling full access to said system and/or a consumable used in said system; (ii) enabling partial access to said system and/or a consumable used in said system; or (iii) denying access to said system and/or a consumable used in said system.
 2. The method of claim 1 wherein said system further comprises a remote interface comprising a direct interface, an indirect interface, or combinations thereof, and said receiving step (a) comprises receiving said system identifier via said remote interface.
 3. The method of claim 1 wherein said enabling step (c)(i) further comprises sending a full access code to a customer and thereby enabling full access to said system.
 4. The method of claim 1 wherein said enabling step (c)(ii) further comprises sending a partial access code to a customer and thereby enabling partial access to said system.
 5. The method of claim 1 wherein said partial access code is adapted to enable use of said system in a demonstration mode.
 6. The method of claim 1 wherein said assay system is configured to use the consumable in the conduct of an assay.
 7. A method of providing consumable data for a consumable, comprising: (a) receiving a query from a customer system via a direct interface for consumable data associated with said consumable, wherein said direct interface comprises an internet connection to said customer system; and (b) sending consumable data for said consumable via said interface to said customer system.
 8. A computer readable medium having stored thereon a computer program which, when executed by a computer system, causes the computer system to perform a method of controlling customer access to an assay system, said method comprising the steps of: (a) receiving a system identifier of the computer system; (b) identifying said system identifier; and (c) utilizing information obtained from the system identifier to perform one or more operations selected from: (i) enabling full access to said assay system and/or a consumable used in said assay system; (ii) enabling partial access to said assay system and/or a consumable used in said assay system; or (iii) denying access to said assay system and/or a consumable used in said assay system.
 9. The computer readable medium of claim 8 wherein said assay system further comprises a remote interface comprising a direct interface, an indirect interface, or combinations thereof, and said receiving step (a) comprises receiving said system identifier via said remote interface.
 10. The computer readable medium of claim 8 wherein said enabling step (c)(i) further comprises sending a full access code to a customer and thereby enabling full access to said assay system.
 11. The computer readable medium of claim 8 wherein said enabling step (c)(ii) further comprises sending a partial access code to a customer and thereby enabling partial access to said assay system.
 12. The computer readable medium of claim 11 wherein said partial access code is adapted to enable use of said assay system in a demonstration mode.
 13. The computer readable medium of claim 8 wherein said assay system is configured to use an assay consumable in the conduct of an assay.
 14. A computer readable medium having stored thereon a computer program which, when executed by a computer system, causes the computer system to perform a method of generating and maintaining consumable data for a consumable, comprising: (a) generating a database comprising consumable data associated with said consumable, wherein said database comprises information adapted to associate said consumable data with said consumable; and (b) maintaining said database on a server.
 15. The computer readable medium of claim 14 wherein said server comprises a master repository including a directory comprising a master consumable data directory, a master system identifier directory, a customer data directory, or combinations thereof
 16. The computer readable medium of claim 15 wherein said master repository comprises an interface to one or more supplemental vendor directories comprising the master system identifier directory, the customer data directory, or combinations thereof.
 17. A computer readable medium having stored thereon a computer program which, when executed by a computer system, causes the computer system to perform a method of providing consumable data for a consumable, said method comprising: (a) receiving a query from a customer system via a direct interface for consumable data associated with said consumable, wherein said direct interface comprises an internet connection to said customer system; and (b) sending consumable data for said consumable via said interface to said customer system. 